A Study to Evaluate the Effect of Fasting Duration and Tirzepatide Withholding on the Amount of Food and Fluid in the Stomach in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus

Lilly

Status and phase: Not yet enrolling; Phase 1

Conditions: Overweight; Obesity; Diabetes Mellitus, Type 2

Treatments: Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07299084

I8F-MC-GPJE (Other Identifier)

27358

Details and patient eligibility

About

The purpose of this study is to evaluate how fasting and stopping the use of tirzepatide affects the amount of food and drink that stays in the stomach after a meal. Ultrasound will be used to check the stomach content after a test meal.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet one of the following criteria:

  • Have type 2 diabetes
  • Have obesity
  • Have overweight with at least one health issue related to weight but without type 2 diabetes

Exclusion criteria

• Have a condition that affects how their stomach empties
• Have had weight loss surgery
• Have type 1 diabetes
• Have any major medical conditions or histories that could interfere with the study

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Participants with Type 2 Diabetes

Experimental group

Description:

Participants will receive tirzepatide subcutaneously (SC)

Treatment:

Drug: Tirzepatide

Participants with Overweight or Obesity Without Type 2 Diabetes

Experimental group

Description:

Participants will receive tirzepatide SC

Treatment:

Drug: Tirzepatide